Principal Biostatistician

Job Title: PrincipalBiostatistician Location:Hyderabad JobType:FullTime
KeyResponsibilities:
1.Biostatistical Analysis and Strategy:Develop statistical analysis plans for clinicaltrials. Collaborate with clinical teams todesign studies and determine primaryendpoints.
2.Statistical Methodology: Apply advancedstatistical methodologies for data analysis.Ensure appropriate implementation of statisticaltechniques.
3.Regulatory Compliance and Documentation:Maintain compliance with global regulatory standards (FDA EMA etc.)in statistical analysis. Prepare statisticalsections of regulatory submissiondocuments.
4.Data Interpretation and Reporting: Interpretstatistical results in the context of clinicaltrials. Generate comprehensive reports andpresent findings tostakeholders.
5.Collaboration with CrossFunctional Teams:Work closely with Data Management and Clinical Operationsteams. Provide statistical input during thedata collection and analysisphases.
6.Project Management: Manage biostatisticalaspects of multiple clinical trials. Ensuretimely delivery of statisticaloutputs.
7.Client Engagement and Communication: Act asa statistical consultant for clients and internalteams. Communicate complex statisticalconcepts in an understandablemanner.
8.Quality Assurance: Perform quality controlof statistical analyses and outputs. Ensurethe accuracy and reliability of statisticaldeliverables.
9.Professional Development and KnowledgeSharing: Stay updated with the lateststatistical techniques and industry trends.Participate in and contribute to professional forums andconferences.
Qualifications: Education:Master s or PhD in Biostatistics Statistics or a relatedfield.
Experience: Proven experience in biostatistics preferably in clinical trialsfor more than 10 years. Familiarity withFullService Provider (FSP) and clientfacingenvironments.
Skills: Excellent analytical skills and proficiency in statistical software(SAS R etc.). Strong communication andcollaboration abilities. Capable oftranslating statistical findings into actionableinsights.
AdditionalRequirements:
Ability to work both independently andcollaboratively. Adaptability to changingrequirements and deadlines. Committed toongoing professional growth anddevelopment.

sas,r,clinicaltrials,fsp,communication,collaboration,biostatistics,qualityassurance,statistical analysis

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